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Blood, Vol. 111, Issue 1, 25-41, January 1, 2008 This Article Abstract Full Text Services Email this article to a friend Alert me to new issues of the journal Rights and Permissions Citing Articles Citing Articles via CrossRef Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update Blood Rizzo et al. 111: 25 Updated Addendum: July 30, 2008 FDA label information Effective July 30, 2008, the U.S. Food and Drug Administration (FDA) mandated the following changes to the labels for the Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) and Darbepoetin alfa (marketed as Aranesp):     • ESAs are no longer indicated for patients receiving myelosuppressive chemotherapy if the anticipated treatment outcome is cure. They remain indicated when myelosuppressive chemotherapy is intended for palliation.      • ESAs should not be initiated if the patient’s hemoglobin is above 10 g/dL. Further, the label change ○ specifies that ESA treatment should target the lowest hemoglobin concentration that will avoid transfusion, ○ removes “...or exceeds 12 g/dL” as an upper range for ESA use, and ○ removes language that allowed earlier initiation of ESAs, or treatment to higher hemoglobin targets, if the patient cannot tolerate anemia due to a comorbid condition. The labels’ boxed Warnings now read: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. The warning is no longer focused on studies with hemoglobin targets at or above 12 g/dL. Addendum: new FDA label information The FDA announced revisions to the product labels for ESAs on Nov. 8, 2007. The guideline panel is considering the label changes to assess their relevance to the 2007 recommendations. The new label information can be found at http://www.fda.gov/cder/foi/label/2007/103234s5158lbl.pdf. This Article Abstract Full Text Services Email this article to a friend Alert me to new issues of the journal Rights and Permissions Citing Articles Citing Articles via CrossRef

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